EPISALVAN Gel Ref.[50043] Active ingredients: Betulin

Posology

The gel should be applied to the wound surface at a thickness of approximately 1 mm and covered by sterile wound dressing. The gel should be re-applied at each wound dressing change, until the wound is healed, for up to 4 weeks (see section 4.4 “wound size” and “duration of use”).

Special populations

Renal or hepatic impairment

No formal studies have been conducted with Episalvan in patients with renal or hepatic impairment. No dose adjustment or special considerations are anticipated for patients with renal or hepatic impairment (see section 5.2).

Elderly

No dose adjustment is required.

Paediatric population

The safety and efficacy of Episalvan in children and adolescents under 18 years have not yet been established. No data are available.

Method of administration

For cutaneous application.

Fresh wounds should achieve haemostasis prior to application of Episalvan. If necessary, wounds (accidental wounds) should be cleaned according to standard procedure, using e.g. wound antiseptic solution, prior to application of Episalvan.

Episalvan is for single use only.

Overdosing with Episalvan is unlikely: in patients in which wound sizes >300 cm² were repeatedly treated with Episalvan, no betulin plasma levels could be detected.

No data have been generated to study the effect of accidental ingestion of Episalvan.

4 years.

Once opened, the product should be used immediately and be discarded after use.

Store below 30°C.

White collapsible aluminium tube, interior lacquered with epoxy phenolic coating, and with a sealing compound in the fold. The tubes are closed with a tamper-evident aluminium membrane and fitted with a white polypropylene screw cap. The tube is packed in a cardboard box.

Pack size: 1 tube containing 23.4 g gel.

No special requirements.